By Dr. Carrie Wolinetz, OSTP Deputy Director for Health and Life Sciences
Grail Sipes, Assistant Director for Biomedical Regulatory Policy
The COVID-19 pandemic illustrated both the best- and worst-case scenarios for conducting clinical research in the face of a health-related emergency. The large-scale COVID vaccine trials, the RECOVERY trial in the United Kingdom, and the National Institutes of Health-led public-private partnership known as ACTIV all demonstrated the tremendous power of organized and coordinated clinical research efforts to understand an emerging virus and rapidly develop medical countermeasures. But we also saw a host of well-intended but fragmented trials launched, with poor design and low enrollment rates unlikely to yield actionable results. This represents a waste of scientific capital and funding resources, and also wastes the contributions of people who volunteer for clinical trials. With the risks of pandemics and other public health threats increasing, this is an inefficiency we can ill afford.
In an earlier blog post, we highlighted some of the critical goals set forth in the National Biodefense Strategy. One of those goals is to build and maintain a United States clinical trials infrastructure that is capable of responding to outbreaks of disease and other biological incidents on an emergency basis – for example, by maintaining an ability to launch clinical trials within 14 days of the identification of a viable candidate countermeasure.
To achieve this goal, we need to revisit processes currently in place within our clinical trials infrastructure that can lead to the fragmentation and inefficiency described above. At the most basic level, if there is no pre-existing, coordinated plan for emergency clinical research, individual researchers and institutions will tend to launch their own studies when an emergency strikes. Our clinical trial enterprise needs to be ready to work together in the event of an emergency. We need to develop a base of ongoing clinical trial activity across a broad range of sites that can support coordinated, larger-scale studies when the need for emergency research arises. We need a process for developing emergency clinical trial protocols, and for capturing trial data through consistent data elements reported across participating sites. And we need to carry out clinical research in a way that increases diversity among trial participants as well as among the investigators who lead clinical trials. This is critical not only to ensure equity, but to ensure the quality of our research results.
In support of this goal, today the White House Office of Science and Technology Policy (OSTP) – in coordination with the National Security Council – is issuing a Request for Information (RFI) to hear from stakeholders on how we might build the clinical research capacity needed to appropriately respond in the event of an emergency. From now through December 27, 2022, we are seeking comment from all stakeholders, across the country, on how we can do this better. What do institutions and scientists need to keep the research base warm and ready for action? How can we get the enterprise rowing in the same direction from day one, asking the right scientific questions, and efficiently coordinating resources? How do we ensure that all Americans and all communities have the opportunity to participate in high-quality, impactful clinical research studies? And how can we make sure this is organized and governed appropriately, across public and private sectors? Are there opportunities to make advance agreements to streamline the research response in real time?
OSTP will also soon seek input on how best to operationalize protocol distribution and data capture from a technical perspective in a separate RFI. More on that in an upcoming post.
While ensuring that our clinical research enterprise is prepared to respond quickly and smoothly in the event of an emergency is critical to address pandemics and to our biodefense, we also feel confident that these efforts will have benefits for science beyond emergencies. Finding new ways to support well-designed, inclusive clinical trials is a worthwhile goal for improving the health of the American people, regardless of whether it is in response to an infectious disease outbreak or to address deadly diseases like cancer or heart disease.
We are at a critical moment to absorb the lessons of what worked well and what didn’t during the COVID-19 pandemic, and the National Biodefense Strategy lays out bold outcomes to prepare our country for future biological threats. As a government and as a nation, we need to work towards solutions that will allow a faster, more efficient, more equitable response to the next outbreak. And that’s going to require hearing from the people on the ground, so we are hoping for a robust response to our RFI.